Staff IRB IACUC Biosafety Training

 

Expedited Review Research

 

At times research can be reviewed more quickly by one or more experienced IRB members either because the research is found by the reviewer(s) to involve no more than minimal risk and the protocol's procedures must be listed as one of the categories in the Federal regulations' list of procedures that qualify for an expedited review process. Minimal risk is defined as "where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or test".

 

The expedited review process may not be used where potential risks prove to be greater than minimal, i.e. could potentially cause harm beyond that which would normally be encountered by the participant in every day life. These include:

 

Physical risks: if revelations about others get back to those persons, particularly when researchers study domestic violence, or through the administration of any substance.
Emotional or psychological risks: when a research interaction causes upset, or worry about breach of confidentiality, or questions about emotional or traumatic events stirs up depression, worry or anxiety.
Moral risks: when participation in research strengthens subjects' inclinations to behave unethically.

 

Research where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or may be stigmatizing can not undergo expedited review.

 

General examples of research conducted at UMBC to help plan a study may be found here.

 

Student investigators performing independent research or conducting senior theses, master's projects and doctoral dissertation research - please review the application and review information found here.

 

The following are instructions for preparing an application for Expedited Review:

 

1) Complete the Collaborative Institutional Training Initiative (CITI) training program

 

2)  Make the preliminary determination that a research project is eligible for expedited. This judgment should be made with care - review the Human Subject Regulations Decision Charts from OHRPand this list of expedited review research categories. Questions of interpretation may be directed to the Human and Animal Protections Research Office (HARPO@umbc.edu).

 

3) List all members of the research team (if applicable) who will be involved in the study. If not known at the time of the application, these names may be forwarded to the Human and Animal Protections Research Office when hired.  All members must have completed the CITI training before engaging participants in the study.

 

4) Complete the below appropriate forms that are applicable to your project; at the minimum complete the Application for Approval of Use of Human Participants and Informed Consent documents. When completing the application forms, please keep the use of jargon or technical terms at a minimum. Otherwise, provide an explanation of these terms within the body of the proposal.  Review of protocols are performed by someone who may not be familiar with the investigator's field or discipline.  Be sure to follow all instructions on the forms.

 

Click to download the:

 

Application for Approval of Use of Human Participants

Instructions for developing a consent form

Blank Consent Form

Parent Consent (permission) Form

Waiver of written informed consent request

Instructions and format for assent

 

4) Electronically submit the protocol and any accompanying documents to irbsubmissions@umbc.edu. The Human and Animal Protections Research Office prefer applications submitted in MS Word format, but Adobe Acrobat versions will be accepted also. Please do not submit “hard-copy” or paper documents.

 

Please be sure to include the applicable pages with the signature of the investigators. A scanned version as a PDF document is acceptable. If that's not possible, fax that page (and that page only) to the Human and Animal Protections Research Office at (410) 455-3868. Protocol applications will not be processed until this face page is received. Copies of approval documentation from collaborating institutions, which must accompany the protocol submission, may be faxed if electronic versions are not available.

 

Applications for expedited review may be submitted at any time to the Human and Animal Protections Research Office preferably four (4) weeks before an investigator intends to begin a project. This will allow sufficient time for the review and approval process to take place.

 

Investigators will be notified of the IRB's decision of approval approximately three weeks following submission.

 

 

 

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Didn’t find what you needed? Contact the HARPO staff at 410-455-2737, HARPO@umbc.edu or Instant Message to AIM Screen name HARPO246